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An Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191516
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
History of Changes

September 12, 2005
January 24, 2007
October 2004
Not Provided
Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24
Same as current
Complete list of historical versions of study NCT00191516 on ClinicalTrials.gov Archive Site
  • Pediatric Adverse Events Rating Scale (PAERS) during 8 and 24 weeks of treatment.
  • O'Brien Sleep Questionnaire during 8 and 24 weeks of treatment
Same as current
Not Provided
Not Provided
 
An Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder
An Open-Label Study on Effectiveness and Tolerability of Atomoxetine as Perceived by Patients, Parents, and Physicians in Children With Attention-Deficit/Hyperactivity Disorder in Germany

A single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by patients, parents and physicians, and its impact on quality of sleep in children (aged 6 through 11 years) with Attention-Deficit/Hyperactivity Disorder treated as outpatients in Germany. An 8-week treatment phase is followed by a 16-week extension period.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
Drug: Atomoxetine
Not Provided
Wehmeier PM, Schacht A, Dittmann RW, Banaschewski T. Minor differences in ADHD-related difficulties between boys and girls treated with atomoxetine for attention-deficit/hyperactivity disorder. Atten Defic Hyperact Disord. 2010 Jun;2(2):73-85. Epub 2010 Mar 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
257
February 2006
Not Provided

Inclusion Criteria:

  • Male or female outpatients who are at least 6 years of age and who will not have reached their 12th birthday
  • Diagnosis of ADHD
  • Normal intelligence

Exclusion Criteria:

  • Weigh less than 20 kg or more than 60 kg at study entry
  • Other relevant psychiatric diagnoses
  • Are at serious suicidal risk as determined by the investigator
  • Have a history of severe allergies
  • Alcohol or drug abuse within the past 3 months
Both
6 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00191516
9496, B4Z-SB-LYDD
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
Study Chair: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP